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Table 6 Methodologic rigor

From: An overview of the design and methods for retrieving high-quality studies for clinical care

Purpose category Methodologic rigor
Etiology Observations concerned with the relationship between exposures and putative clinical outcomes;
Data collection is prospective;
Clearly identified comparison group(s);
Blinding of observers of outcome to exposure.
Prognosis Inception cohort of individuals all initially free of the outcome of interest;
Follow-up of ≥ 80% of patients until the occurrence of a major study end point or to the end of the study;
Analysis consistent with study design.
Diagnosis Inclusion of a spectrum of participants;
Objective diagnostic ("gold") standard OR current clinical standard for diagnosis;
Participants received both the new test and some form of the diagnostic standard;
Interpretation of diagnostic standard without knowledge of test result and vice versa;
Analysis consistent with study design.
Treatment Random allocation of participants to comparison groups;
Outcome assessment of at least 80% of those entering the investigation accounted for in 1 major analysis at any given follow up assessment;
Analysis consistent with study design.
Economics Question is a comparison of alternatives;
Alternative services or activities compared on outcomes produced (effectiveness) and resources consumed (costs);
Evidence of effectiveness must be from a study of real patients that meets the above-noted criteria for diagnosis, treatment, quality improvement, or a systematic review article;
Effectiveness and cost estimates based on individual patient data (micro-economics);
Results presented in terms of the incremental or additional costs and outcomes of one intervention over another;
Sensitivity analysis if there is uncertainty.
Clinical Prediction Guide Guide is generated in one or more sets of real patients (training set);
Guide is validated in another set of real patients (test set).
Review articles Statement of the clinical topic;
Explicit statement of the inclusion and exclusion criteria;
Description of the methods;
≥ 1 article must meet the above noted criteria.